MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TFOCUS; BLOOD GLUCOSE SYSTEM

Model Number	TFOCUS
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-55: user had an inaccurate reference: competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system.Test strips udi: (b)(4).Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for lo blood glucose test results.The customer is concerned with test results obtained of lo fasting.The customer's expected fasting blood glucose test result range is 80 - 100 mg/dl.Customer stated that after he obtained the result of lo, he performed a blood using another device within two minutes and obtained a result of 105 mg/dl fasting.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a back to back blood test was not performed by the customer.The test strips are new from the pharmacy; test strip lot manufacturer's expiration date is 08/29/2020 and open vial date is 07/11/2019.The meter memory was reviewed for previous test result history: (b)(6).

• Brand Name: TFOCUS
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8861674
• Report Number: 1000113657-2019-00789
• Device Sequence Number: 19269106
• Product Code: NBW
• UDI-Device Identifier: 00021292007744
• UDI-Public: (01)00021292007744
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K131013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/29/2020
• Device Model Number: TFOCUS
• Device Lot Number: NV1000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1